Kornimate/medical-research-clean huggingface dataset:
celebrex in acute gouty arthritis study

Conditions: Arthritis, Gouty

Summary: this is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.


Eligibility criteria:
inclusion criteria: * acute gouty arthritis meeting the american college of rheumatology (acr) criteria for acute arthritis of primary gout; * onset of pain from an acute gouty arthritis attack within 48 hours prior to screening/baseline (visit 1); * a rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the patient's assessment of pain intensity in the index joint (5-point scale:0-4) at screening/baseline. exclusion criteria: * diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint; * acute polyarticular gout involving greater than 4 joints or chronic gout.
echocardiographic assessment of function during ecmo support

Conditions: Cardiac Failure; Extracorporeal Membrane Oxygenation Complication

Summary: the purpose of this study is to evaluate echocardiographic markers of cardiac function to assess the ability of patients to successfully end va-ecmo support.

1. what is the major problem being addressed by this study? extracorporeal membrane oxygenation (ecmo) is a machine used to do the work of the heart and lungs when children's hearts or lungs are too sick to perform normally. veno-arterial (va) ecmo therapy for poor heart function provides support that can lead to patient recovery, transplantation if appropriate and eligible, or complications of ecmo therapy lead to stopping care. each day a patient is on ecmo, complications can occur that require stopping support, and attempting to get off ecmo as quickly as possible is important. there is currently no consistent way of assessing heart function while patients are supported by va-ecmo to help guide when children's hearts have improved enough to survive without the help of ecmo. 2. what specific questions are you asking and how will you attempt to answer them? the specific question we are asking is whether newer ultrasound measures of heart function can predict which patient may be well enough to be able to come off of ecmo support. we are following critically ill patients and performing multiple measurements at specific time points to look for changes in those patients whose heart function recovers and in those patients who do not recover function. the ultrasound measurements will be performed during changes in the amount of support provided by the ecmo machine. * 3. what is the long-term biomedical significance of your work, particularly as it pertains to the cardiovascular area? what major therapeutic advance(s) do you anticipate that it will lead to? for instance, new drug(s), a surgical technique/procedure, a diagnostic tool/test, a previously undetected risk factor, etc. our long term goal is to develop non-invasive, quantitative measures of cardiac function for patients needing ecmo support to help guide care. ultimately if deemed successful, these measurements could be used by all physicians who care for these patients. this study could lead to more efficient prediction of who needs to stay on ecmo and who could be removed. this could help to improve survival and decrease complications in some of the sickest children. these measurements may also help us to identify, at an early stage, those patients whose hearts are too sick to recover and will need a heart transplant evaluation.

Eligibility criteria:
inclusion criteria: * va ecmo (all cannulation sites) * primary cardiac failure * septic shock exclusion criteria: * vv ecmo * primary respiratory failure * congenital diaphragmatic hernia * persistent pulmonary hypertension of the newborn * greater than 1 source of systemic perfusion
the predictive value of hepatocyte growth factor and soluble receptor s-met in sepsis

Conditions: Sepsis

Summary: to observe the changes of plasma hepatocyte growth factor and soluble receptor s-met levels in patients with sepsis, and to explore its clinical significance.

90 patients who diagnosed as sepsis were included in this study. then keep blood samples from these patients in the first day, the third day, detect the hepatocyte growth factor and soluble receptor s-met level in plasma byenzyme-linked immuno sorbent assay. record severity of illness and survival status of every patient within 28 days. objective to evaluate the correlation between the level of hepatocyte growth factor and soluble receptor s-met in plasma and the prognosis of the patients.

Eligibility criteria:
inclusion criteria: 1. patients admitted to icu diagnosed of sepsis(sepsis3.0 criteria) 2. patients signing informed consent exclusion criteria: 1. age is less than 18 years old or more than 80 years old 2. pregnant women 3. patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、hellp syndrome 4. prothrombin time is extension in patients with after liver transplantation 5. patients with chronic renal failure 6. patients after kidney transplantation
long-term safety follow-up study of patients having received hepastem (saf001)

Conditions: Urea Cycle Disorders; Crigler Najjar Syndrome

Summary: the purpose of this study is to assess the long-term safety follow-up of patients having been treated with hepastem.

the primary objective of the saf001 study is the long-term safety surveillance of the patients post infusion with hepastem. furthermore, the evolution of both the metabolic condition and the quality of life are followed. as much as possible, the surveillance will mimic the standard follow-up of the respective diseases (standard of care). the surveillance will end when the patient is undergoing an organ transplant or takes part in another research study. this surveillance will last up to a maximum of 48 months.

Eligibility criteria:
main inclusion criteria: - subject having received hepastem during a former interventional clinical study and who have terminated their participation in that study. exclusion criteria: - subject has received mature liver cells, stem cells transplantation other than hepastem, or organ liver transplant.

Keywords: cn ucd
the antibacterial effect of nanosilver fluoride on primary teeth

Conditions: Primary Teeth; Microbial Colonization; Caries; Dental Caries in Children

Summary: to assess the antibacterial effect of nanosilver fluoride (nsf) in relation to caries activity in dentin caries lesions of primary teeth in comparison to silver diamine fluoride (sdf).

fifty children aged 4 to 6 years old with active dentin caries lesions (score 5 according to international detection and assessment system (icdas ii) criteria) will be enrolled in the study. they will be equally and randomly allocated into 2 groups: a group receiving nsf and a control group receiving sdf treatment. microbiological samples will be collected from the carious lesions and from unstimulated saliva at the baseline and at the 1 and 3 months' follow-up appointments. bacterial counts will be assessed using mitis salivarius agar (selective culture media for s. mutans) and rogosa agar (selective culture media for lactobacilli), and the results will be expressed in colony-forming units. data regarding the children's oral health will be collected and their dmf index will be scored. the arrest of active carious lesions will be measured at the follow-up appointments according to icdas ii criteria.

Eligibility criteria:
inclusion criteria: * the presence of at least one active carious lesion on a primary tooth. * completion of an informed consent to participate in the study. exclusion criteria: * children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling, abscess, obvious discoloration of the tooth, or premature mobility. * reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks. * children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow. * allergy or sensitivity to silver or any of the materials included in the study. * child weight less than 10 kg (to avoid concerns for toxicity).

Keywords: nano silver fluoride silver diamine fluoride antibacterial caries arrest microbiology primary teeth pediatric clinical trial nanosilver sdf
all in one study: a prospective trial of electromagnetic navigation for biopsy of pulmonary nodules

Conditions: Lung Cancer

Summary: this is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.

the objectives of this study are to evaluate diagnostic yield following biopsy of peripheral pulmonary nodules as identified on chest computed tomography (ct) utilizing (1) electromagnetic navigation (emn) bronchoscopy, and/or (2) emn-transthoracic needle aspiration (ttna). overall diagnostic yield will be evaluated to assess the combination of these approaches.

Eligibility criteria:
inclusion criteria: * the patient is ≥21 years old, * the patient has a lung nodule identified on chest ct and is a candidate for elective emn bronchoscopic evaluation as determined by the treating pulmonologist, * the size of the target nodule, as measured at its greatest diameter, is between 1-3cm, * staging at the time of enrollment indicates no/n1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum), * the patient has an intermediate risk of malignancy (5-65% per the mayo model) and is in need of diagnosis for alternative treatment, or the patient has a high probability of cancer (\>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (sbrt). note: if the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study, * the patient has a lack of bleeding disorders, and * the patient is willing and able to provide informed consent. exclusion criteria: * the patient is pregnant as confirmed by urine or serum pregnancy testing, * the patients has a body mass index (bmi) \>40, * there is a predetermined plan to pursue stereotactic body radiation therapy (sbrt) in the event of a nondiagnostic study procedure in patients with a nodule within spinperc range (i.e. the patient would not go on for a ct guided ttna), or there is a predetermined plan to pursue stereotactic body radiation therapy (sbrt) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before sbrt.
long-term safety and effectiveness of augment® bone graft compared to autologous bone graft

Conditions: Ankle and Hindfoot Arthrodesis

Summary: the objective of this long-term study is to evaluate the long term effectiveness and safety of augment® bone graft vs. autologous bone graft. the study involves evaluation of subjects originally treated under protocol bmti-2006-01. subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol bmti-2006-01. study hypothesis: the effectiveness and safety profile for augment® bone graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up. regulatory phase: post-approval study


Eligibility criteria:
inclusion criteria: subjects who meet the following criteria may be included in the study: 1. must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and 2. must have been randomized, treated and included in the safety population of protocol bmti-2006-01 (see exhibit 13.1). exclusion criteria: 1) subjects that were excluded from the safety analysis in the bmti-2006-01 study (subjects not listed in exhibit 13.1). these subjects were consented, but never treated as part of the bmti-2006-01 protocol.

Keywords: ankle fusions augment® bone graft autologous bone graft arthritis ankle pain foot pain hindfoot fracture ankle fracture
neuropsychological assessment of the oldest-old population.(neuropsic-gr)

Conditions: Dementia; Cognition Disorders in Old Age

Summary: neuropsychological tests currently considered to evaluate the cognitive performance of the oldest-old population (more than 80 years) are not adapted to this group population. this trial aims to determine the normal limits for this group population of a set of 18 neuropsychological test. results may improve the diagnostic cognitive evaluation of this population.

120 subjects more than 80y old (non-institutionalized) grouped in 4 age categories (80-84, 85-89, 90-94, 95 or more) will be evaluated through 18 neuropsychological tests (usually considered at memory clinics). subjects will be recruited from 5 primary care centers by a random selection method (stratified by age group). normal limits will be defined by the percentiles of test punctuation. previously, punctuation will be adjusted by age and education level by lineal regression.

Eligibility criteria:
inclusion criteria: * 80 or more years old * residence at comarca del garraf * able to be transfered to study center * sufficient reading and writing capacity to carry out the neuropsychological tests, at the evaluator's discretion. exclusion criteria: * patient at end-of-life situation or with a very short life expectancy (days-weeks). * hospital admission in the previous 3 months. * history of relevant mental illness: major depression, psychosis, bipolar disorder, obsessive-compulsive disorder. * disease of the central nervous system with possible cognitive impairment: parkinson's disease, multiple sclerosis, brain tumor, stroke with cognitive impairment, epilepsy, severe traumatic brain injury. * history of alcoholism or substance abuse. * severe sensory deficit that prevents performing neuropsychological tests, at the discretion of the evaluator. * positive shortened spanish informant questionnaire for cognitive decline in the elderly questionnaire (ss-iqcode) or lobo's cognitive mini-examination test (spanish adaptation of minimental of folstein test) with a score \< 23 (20 in people with low schooling or illiteracy). * dementia criteria according to the diagnostic and statistical manual of mental disorders iv.

Keywords: geriatric assessment aged, 80 and over dementia cognition disorders in old age
nitro oxide inhalation continued with sildenafil on neonatal persistent pulmonary hypertension

Conditions: Persistent Pulmonary Hypertension of Newborn

Summary: nitro oxide (no) inhalation was recognized as an effect treatment of neonatal persistent pulmonary hypertension (pphn), while the safety of no long term application was under investigation. several research suggested too much no2 was generated in the lung after long term (\> 72h) use of no inhalation, which cause bad effects on ps production. sildenafil was proved to be effective to pphn as no. this medication has a similar clinical effect but need monitoring of blood pressure. the possible hypotension effect restrict the dosage of sildenafil, which limit the usage of sildenafil in severe pphn. but we recommend sildenafil to the purpose of the study was to establish if no continued with sildenafil has the same effect as single no inhalation.


Eligibility criteria:
inclusion criteria:diagnosed as pphn in the nicu,primary disease:neonate respiratory distress syndrome,meconium aspiration syndrome of newborn,severe neonatal infectious pneumonia. * pulmonary artery pressure \> 50mmhg * mechanical ventilation over 48h * primary oi(po2/fio2)\<300 * difference of spo2 between up and low limbs \> 10% * high fio2 oxygen inhalation test: positive exclusion criteria: * congenital heart disease * diaphragmatic hernia

Keywords: pphn no inhalation sildenafil treatment safety
dose-ranging study to evaluate efficacy and safety of weekly cjc-1134-pc in patients with t2dm on metformin monotherapy

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: dm200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of cjc-1134-pc in patients with type 2 diabetes mellitus on metformin monotherapy.

dm200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of cjc-1134-pc in patients with type 2 diabetes mellitus (t2dm) on metformin monotherapy. this study will be a randomized, double-blind comparison of cjc-1134-pc versus placebo. patients taking metformin will continue to take their metformin at the same dose for the duration of the study. patients with t2dm, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. all patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period. cjc-1134-pc or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. patients will be closely monitored and evaluated for toxicity on an ongoing basis.

Eligibility criteria:
inclusion criteria: * men or women 18 to 70 years of age, inclusive * body mass index of 27 to 45 kg/m2 * diagnosed with t2dm for at least 6 months before screening * stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening * fpg ≤240 mg/dl at screening * hba1c ≥7.0% and ≤11% at screening * a 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected qt interval exclusion criteria: * pregnant or breastfeeding women * use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening * treatment with any oral antidiabetic agent other than metformin within the 3 months before screening * treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening * previous treatment with a glucagon-like peptide 1 (glp-1) analog or other incretin therapy * receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening

Keywords: type 2 diabetes mellitus t2dm diabetes conjuchem glp-1 glucagon-like peptide-1 exendin-4 modified exendin-4
assessment of shared decision making aids in asthma

Conditions: Asthma

Summary: the purpose of this study is to determine whether the use of shared decision making aids is more effective than usual care in improving asthma knowledge, lessening decisional conflict, and enhancing adherence to treatments and asthma control in adult patients with mild to severe asthma.


Eligibility criteria:
inclusion criteria: 1. men or women, aged 18 to 65 years; 2. current diagnosis of mild to severe asthma; 2.1) asthma diagnosis will be made upon one of the following criteria: 2.1.1) forced expiratory volume in one second (fev1) increases by at least 12% after the use of a bronchodilator (and a minimum ≥ 200 ml); 2.1.2) current asthma symptoms and a positive methacholine challenge test (20% fall in fev1 after inhalation of a provocative dose of methacholine 16 mg/ml); 2.1.3) a respirologist's current diagnosis of asthma found in the patient's medical report. 2.2) severity of asthma will be assessed according to prescribed pharmacotherapy, as suggested by the 2012 canadian thoracic society guidelines: 2.2.1) patients with mild asthma using saba as well as low doses (≤250 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids; 2.2.2) patients with moderate asthma using saba as well as low to moderate doses (250mcg/day \ 500 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids, and additional pharmacotherapy (laba, ltra, or prednisone), and saba. exclusion criteria: 1. chronic obstructive pulmonary disease (copd); 2. education on asthma in the last 6 months.
assess increased mortality risk with each year of delayed tobramycin solution (tis) initiation, and effect of tis on mortality across study centers

Conditions: Cystic Fibrosis

Summary: using cff registry data, this analysis will: describe patterns of time to tis initiation from first year of tis eligibility, estimate the increased risk of death attributable to each year of delayed tis initiation, and investigate tis effects across study centers.


Eligibility criteria:
inclusion criteria: * ≥6 years of age with a documented cystic fibrosis (cf) diagnosis, * moderate-to-severe lung disease, * pseudomonas aeruginosa (pa) airway infection. exclusion criteria: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cystic fibrosis
influences of gingival cord retractor in retention rate of non-carious cervical lesions restorations.

Conditions: Dental Wear; Tooth Wear

Summary: the aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of non-carious cervical lesion. the presence of gingival displacement with a retraction cord (yes or no) and the category of adhesive system (etch-and-rise and self-etching) will be evaluated. data will be collected, tabulated and submitted to statistical analysis.

cervical wear is classified as a noncarious cervical lesion (nccl), which is a pathological process characterized by loss of dental hard tissues near the cementoenamel junction (cej). the aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of non-carious cervical lesion. the presence of gingival displacement with a retraction cord and the category of adhesive system will be evaluated. two hundred and twenty teeth, with nccl of depth greater than 1.5mm, of 55 healthy patients of both sexes will be select. the teeth will be randomly divided into 4 different groups according to the gingival displacement with retraction cord (yes or no) and adhesive system category (etch-and-rise and self-etching). data will be collected, tabulated and submitted to statistical analysis.

Eligibility criteria:
inclusion criteria: * healthy volunteers; both genres; presence of at least four non carious cervical lesions of similar dimensions in the same arc and opposite quadrants; good oral hygiene. exclusion criteria: * presence of cavities, cracks or enamel fractures; extensive or unsatisfactory restorations; recent restorations involving the labial surface; dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.